CLOSYS- sodium fluoride paste, dentifrice

CloSYS by

Drug Labeling and Warnings

CloSYS by is a Otc medication manufactured, distributed, or labeled by Rowpar Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium fluoride 0.24% (0.13% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor

children under 6 years of age: instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years of age: consult a dentist or doctor

• supervise children as necessary until capable of using without supervision
• do not swallow

Inactive ingredients

water, hydrated silica, stabilized chlorine dioxide, sarkosyl (coconut derived), disodium hydrogen phosphate, cellulose gum, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sucralose, menthol crystals

Questions or comments?

call 1-800-643-3337

Principal Display Panel

NEW LOOK Same Formula

A Cleaner Mouth.

A Healthier You.

CloSYS®

Non-Irritating TOOTHPASTE

Midly Flavored for

SENSITIVE

Mouths

Anticavity Fluoride

Enamal Protection

GENTAL MINT Flavor

NET WT. 7.0 oz (198g)

ADA Accepted

American

Dental

Association

INGREDIENTS AND APPEARANCE

CLOSYS 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58578-0749
Route of Administration	ORAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CHLORINE DIOXIDE (UNII: 8061YMS4RM)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHOL (UNII: L7T10EIP3A)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58578-0749-1	1 in 1 BOX	10/20/2017
1		96 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58578-0749-2	1 in 1 BOX	10/20/2017
2		198 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 58578-0749-3	1 in 1 BOX	10/20/2017
3		21 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/20/2017

Labeler - Rowpar Pharmaceuticals, Inc. (783704661)